Satisfying REACH requirements in predictive toxicology

Invited presentation delivered by Barry Hardy at the "Accomplishments & Challenges in Global Chemicals Policy" session at the IUTOX 2010 conference, 22 July 2010, Barcelona, Spain.
Abstract:
Satisfying REACH Requirements in Predictive Toxicology
Barry Hardy, OpenTox Project Coordinator, Douglas Connect, Baermeggenweg 14, 4314 Zeiningen, Switzerland. Tel: +41 61 851 0170. Email: Barry.Hardy _(at)- douglasconnect.com
The REACH legislation put in place a regulatory framework for the most extensive evaluation of the safety of chemicals that has ever been undertaken. Over 142,000 chemical entities have already been registered that may be subject to assessment in coming years. Any organisation involved in the manufacture or import of any chemical at levels over 1 ton/annum into the European marketplace is affected. We will discuss the impacts of this legislation on industry and its economic impacts. How will both large and small companies cope with satisfying REACH requirements? New methods based on computer-based approaches and emerging research areas in chemistry and biology provide alternatives to traditional animal experiments and are included in the REACH chemical safety guidelines. When will the outputs from this research be available for deployment by industry for REACH purposes? In addition to new R&D methods, there is a strong need for coordination between programs and resources. Progress on a well-engineered modernization of predictive toxicology information technology and interoperability between toxicology systems and resources is urgently required. The OpenTox Framework (1) has been developed to support the communication between toxicology resources, based on standard representations of data, and the ability for distributed resources to exchange that data, build and validate models, and generate report information relevant for REACH. We will discuss the approach of OpenTox and related developments and initiatives, current challenges and future directions, including the need and benefits for collaborative approaches and the infrastructure requirements for supporting interdisciplinary science.
(1) OpenTox - An Open Source Predictive Toxicology Framework, is funded under the EU Seventh Framework Program: HEALTH-2007-1.3-3 Promotion, development, validation, acceptance and implementation of QSARs (Quantitative Structure-Activity Relationships) for toxicology, Project Reference Number Health-F5-2008-200787 (2008-2011). More information at www.opentox.org